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Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD — ADHD  

Attention-Deficit/Hyperactivity Disorder (ADHD) Clinical Trial

Official title:
A Phase IV, Open-Label, Flexible-Dose Safety Trial Evaluating SPN-812 Administered With Psychostimulants in Children and Adolescents (6 to 17 Years of Age) With Attention-Deficit/Hyperactivity Disorder (ADHD)

Clinical Trial Summary

This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).

Clinical Trial Description

This is an open-label, multicenter, flexible-dose, safety study of SPN-812 in pediatric patients (6-17 years of age) diagnosed with ADHD, when administered with a FDA-approved medication (psychostimulant) in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in pediatric subjects. Participants will be screened for eligibility for up to 4 weeks, and he/she will continue to take their prescribed psychostimulant ADHD medication during that time. Following the screening period, eligible subjects will receive SPN-812 with their current psychostimulant treatment for ADHD for 8 weeks. For the first 4 weeks of treatment subjects will take SPN-812 dose in the morning (AM dosing), and for the last 4 weeks of treatment, subjects will take SPN-812 dose in the evening (PM dosing). The total duration of the study between the screening visit and the end of the treatment period/end of study (EOS) visit is up to 12 weeks. ;

Study Design

Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention-Deficit/Hyperactivity Disorder (ADHD)
  • Hyperkinesis
Clinical Trial Details
NCT number NCT04786990
Study type Interventional
Source Supernus Pharmaceuticals, Inc.
Contact
Status Completed
Phase Phase 4
Start date July 27, 2021
Completion date July 26, 2023
View Details
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